Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says.
“Decision No. 3” requires medical devicemakers to put their complete street address on both the device label and instructions for use. The new requirement means companies can no longer list the addresses of post office boxes, sales offices or customer centers. The requirement is set to take effect Sept. 1.
International compliance is no longer simply a matter of following the same old rules. Enforcement activities and practices are changing. Countries are beginning to share data about manufacturing companies, increase the number of inspections and crack down on issues such as counterfeiting and improper marketing. You learn the new rules of the game, or cede the playing field to competitors.
That’s where the FDAnews Guide to International Medical Device Regulation: 2012 Edition comes in. Read through reports on regulatory developments affecting device production in more than 45 nations around the world. There are more than 150 reports highlighting changes from the past year that could supercharge your international sales.
Order your must-have copy of this book today.